A fourth Phase-3 clinical trial in the US to evaluate an investigational COVID-19 vaccine is underway and has started enrolling adult volunteers, the National Institutes of Health (NIH) announced.
The trial is designed to evaluate if the investigational Janssen coronavirus vaccine JNJ-78436725 can prevent symptomatic COVID-19 after a single dose regimen, Xinhua news agency quoted the NIH as saying in a statement on Wednesday. Up to 60,000 volunteers will be enrolled in the trial at up to nearly 215 clinical research sites in the US and internationally.
The Janssen Pharmaceutical Companies of Johnson & Johnson developed the investigational vaccine, and is leading the clinical trial as a regulatory sponsor. It is the fourth large-scale phase 3 clinical trial for a coronavirus vaccine in the US.
The other three trials are for vaccine candidate AZD1222, co-invented by the University of Oxford and its spin-out company Vaccitech; vaccine candidate mRNA-1273, developed by the US National Institute of Allergy and Infectious Diseases (NIAID) and American biotechnology company Moderna; and vaccine candidate BNT162b2, developed by American biopharmaceutical company Pfizer and German company BioNTech.
While the other vaccine candidates require two doses, the Janssen one will be studied as a single-dose vaccine. It is a recombinant vector vaccine that uses a human adenovirus to express the SARS-CoV-2 spike protein in cells.
Pre-clinical findings published in Nature show that the Janssen vaccine induced neutralising antibody responses in rhesus macaques and provided complete or near-complete protection against virus infection in the lungs and nose following SARS-CoV-2 challenge.
The trial is designed primarily to determine if the investigational vaccine can prevent moderate to severe COVID-19 after a single dose.
It also aims to understand if the vaccine can prevent COVID-19 requiring medical intervention and if the vaccine can prevent mild and asymptomatic cases, according to the NIH.
An independent Data and Safety Monitoring Board will provide oversight to ensure the safe and ethical conduct of the study.
"Four COVID-19 vaccine candidates are in Phase 3 clinical testing in the US just over eight months after SARS-CoV-2 was identified," NIAID Director Anthony Fauci said in the statement.